Label: FERROUS SULFATE ENTERIC COATED- ferrous sulfate tablet, coated

  • NHRIC Code(s): 69367-166-04, 69367-166-07, 69367-166-20
  • Packager: Westminster Pharmaceuticals, LLC
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated July 7, 2025

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  • STATEMENT OF IDENTITY

    Supplement Facts
    Serving Size: 1 Tablet
    Amount Per Serving% Daily Value
    Iron (as dried ferrous sulfate) 65 mg361%

    Other Ingredients: Microcrystalline Cellulose, Methacrylic Acid Copolymer, Croscarmellose Sodium, Crospovidone, Hypromellose, Stearic Acid, Polydextrose, FD&C Red #40 Lake, Talc, Triacetin, Sodium Lauryl Sulfate, Silicon Dioxide, Triglycerides, Titanium Dioxide, Glycerol Monostearate, Triethyl Citrate, FD&C Blue #2 Lake and Polysorbate 80.

  • DIRECTIONS

    Adults and children 12 years of age and over: Take one tablet daily, preferably after a meal, or as directed by a physician. Children under 12 years of age: Consult a physician. Do not chew or crush tablet.

    Tablets are enteric-coated to help protect your stomach.

  • WARNINGS

    Do not take within 2 hours of taking oral tetracycline antibiotics, since oral iron products tend to interfere with absorption of tetracycline. May cause gastrointestinal discomfort, nausea, constipation or diarrhea. If you are pregnant or nursing a baby, seek advice of a health professional before using this product.

  • SAFE HANDLING WARNING

    WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
  • Storage

    Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]

  • HEALTH CLAIM

    You may report side effects by calling 1-844-221-7294.

  • HEALTH CLAIM

    Manufactured for:
    Westminster Pharmaceuticals, LLC
    Nashville, TN 37217

    Rev. 02/25

    R53722

    LOT:
    EXP:

  • PRINCIPAL DISPLAY PANEL - 325 mg Tablet Bottle Label

    NEW LOOK

    69367-166-04

    Ferrous Sulfate
    Enteric-Coated Tablets

    Iron Supplement

    325 mg

    (5 Grains)

    100 Tablets

    Westminster
    Pharmaceuticals

    PRINCIPAL DISPLAY PANEL - 325 mg Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    FERROUS SULFATE  ENTERIC COATED
    ferrous sulfate tablet, coated
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:69367-166
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION65 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIACETIN (UNII: XHX3C3X673)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    FD&C BLUE NO. 2 ALUMINUM LAKE (UNII: 4AQJ3LG584)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:69367-166-04100 in 1 BOTTLE, PLASTIC
    2NHRIC:69367-166-071000 in 1 BOTTLE, PLASTIC
    3NHRIC:69367-166-20100 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT08/24/2017
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)11 mm
    imprint
    Labeler - Westminster Pharmaceuticals, LLC (079516651)
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